This course covers all clinical research standards: FDA regulations (IDE, IRBs, etc.), ICH E6, and other international standards. You will be presented with case studies and effective, practical solutions. Providing a comprehensive background and discussing real world implications will build a better understanding as to why each regulation exists. We know that discussing the why's and how's of requirements provides actual value, that is why this training is much more than just “here are the rules, learn them.” Our team assumes you can read.